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Humanitarian Device Exemption

HDE Patient-specific approval

Medicare beneficiaries receiving an HDE device must be approved by Medicare prior to, or within a reasonable time period after, the procedure utilizing the device. Additional information is available in the HDE FAQs. Clinical documentation of the approved indication should be faxed to our Medicare Contractor using the patient specific Request for HDE Treatment Approval form.

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.

Once a device has a HUD designation by the FDA, a humanitarian device exemption (HDE) is required in order to market the device. The FDA does not require that the HDE application contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application must, however, contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.

IRB approval is required in order to use a HUD and, while the FDA does not require specific informed consent for patients receiving HUDs/HDEs, it is an OHSU policy that all HUD/HDE patients sign an IRB-approved consent.

PATIENT SPECIFIC APPROVAL IS REQUIRED FOR ALL MEDICARE PATIENTS RECEIVING A HUD/HDE DEVICE PRIOR TO OR WITHIN 3 DAYS OF IMPLANTATION.